Policy and Procedures for Managing Conflicts of Interest
The following policy governs all International Institute for Restorative Reproductive Medicine (IIRRM) and IRRMA (International Institute for Restorative Reproductive Medicine of America) produced CME activities:
- Any individual in a position to control content must disclose, in their faculty form to IIRRM, the existence of any financial relationships with a commercial interest within the past 12 months. A commercial interest is defined as any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients. Disclosure information must be received and reviewed by IIRRM prior to confirmation of the individual’s participation.
- The online faculty disclosure form is sent to presenters prior to holding the webinar, along with other speaker correspondence.
- Full disclosure is expected and required of any commercial interest, as described on the form, so that the IIRRM can evaluate whether further disclosure to the participants is necessary. Relevant relationships disclosed by presenters do not necessarily disqualify the presenter or their presentation, but will be identified in writing, to allow the audience to determine whether they believe that such a relationship may have any influence on the speaker’s presentation or conclusions. If the presenter refuses to make full disclosure, makes false disclosure, or the disclosure raises issues that in the judgment of IIRRM are irreconcilable with the presentation to be made, the IIRRM may elect to identify a different presenter.
- The webinar representative clarifies any issues that arise with the presenters as necessary.
- The presenting faculty includes either a written statement to be included with the learning objectives distributed before the webinar, or makes a verbal statement at the beginning of the webinar along with a non-disclosure slide including a non-disclosure statement (sample below)
- Sample statements:
SAMPLE STATEMENT #1
This speaker has indicated that (s)he has no relationships to disclose with any manufacturer of any commercial product or services that may be mentioned in (her) his presentation, nor with any commercial supporter of this meeting (if applicable).
SAMPLE STATEMENT #2
This speaker has indicated that (s)he has the following relationships with commercial or proprietary entities that may be related to (her) his presentation:
The intent of this policy is not to prevent individuals from participating, but rather to identify and resolve any conflict of interest. Should resolution be impossible, a replacement for the individual must be chosen.
7. The review, identification, and resolution process must take place prior to the activity.
Resolution of Conflicts of Interest
A. Should no conflict of interest be identified, the individual’s role in the activity may be established.
B. Should a conflict of interest be identified, the individual will be contacted and asked for clarification or additional information. Upon receipt and review of this additional information, methods of resolution will be identified and discussed with the individual. Resolution methods may include, but not be limited to, one or more of the following:
- Peer review of content prior to the activity to ensure evidence-based, un-biased content using best available, highest strength of evidence. The activity faculty must be responsive to revision requirements.
- Modifications or edits of the material, agreed upon between the faculty involved and IIRRM
- Cancellation of the publication or presentation of the material with IIRRM
C. The resolution process and outcome will be documented in the CME activity file
Disclosure of Unlabeled/Investigational Uses of Products
All speakers/faculty must disclose to IIRRM and learners when an unlabeled use of a commercial product, or an investigational use not yet approved for any purpose, is discussed during an educational activity. Speakers/Faculty must disclose that the product is not labeled for the use under discussion or that the product is still investigational.
The intent of this policy is not to prohibit or limit the exchange of views in scientific and educational discussions, including discussions of unapproved uses, but to ensure that faculty discloses to learners that such discussion will take place.
Should an unplanned discussion of unlabeled or investigational uses of a product occur, it is the responsibility of the faculty member to inform the learners that the use under question/discussion is unlabeled or investigational prior to answering the question or responding to the discussion point. If this occurred during a recorded session we ask you declare this to IIRRM on your faculty statement (disclosure form) so we can provide this information to learners before they view the session online.
Acknowledgement of planned discussion of unapproved or investigational uses of products must be presented in writing to the learners prior to the start of the activity, or (for enduring materials) at the point that first mention is made of the unapproved/investigational use in the activity.